Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00004125
• Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.

Detailed Description

OBJECTIVES:

* Compare the disease-free survival and overall survival in patients with node-positive or high-risk node-negative operable stage II or IIIA breast cancer treated with docetaxel or paclitaxel after doxorubicin and cyclophosphamide.

* Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks improves disease-free survival and overall survival when compared with the conventional schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this patient population.

* Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12 weeks versus every 3 weeks for 4 courses in these patients.

* Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly for 12 weeks to that of docetaxel administered on the same schedules in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no more than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs breast conservation surgery). Patients are randomized to one of four treatment arms.

* Arm I: Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4 courses (weeks 1-12). Beginning at week 13, patients receive paclitaxel IV over 3 hours every 3 weeks for 4 courses.

* Arm II: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive paclitaxel IV over 1 hour weekly for 12 weeks.

* Arm III: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses.

* Arm IV: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive docetaxel IV over 1 hour weekly for 12 weeks.

Within 4 weeks after completion of chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen daily for 5 years.

After completion of all chemotherapy, patients with prior segmental mastectomy receive radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical mastectomy may receive radiotherapy after chemotherapy completion at the investigator's discretion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27 years.

Study Timeline

• Study Start: 1999-11-16
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2003-08-22
• Study First Posted: 2003-08-25
• Primary Completion: 2007-05
• Study Completion: 2016-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (48)

State University of New York - Upstate Medical University; 🇺🇸 Syracuse, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.; 🇺🇸 Syracuse, New York, United States

CCOP - Southern Nevada Cancer Research Foundation; 🇺🇸 Las Vegas, Nevada, United States

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

Veterans Affairs Medical Center - Buffalo; 🇺🇸 Buffalo, New York, United States

Schneider Children's Hospital at North Shore; 🇺🇸 Manhasset, New York, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

CCOP - Christiana Care Health Services; 🇺🇸 Wilmington, Delaware, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital); 🇺🇸 Chicago, Illinois, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Hematology Oncology Associates of the Quad Cities; 🇺🇸 Bettendorf, Iowa, United States

Holden Comprehensive Cancer Center at The University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Ellis Fischel Cancer Center - Columbia; 🇺🇸 Columbia, Missouri, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial); 🇺🇸 Columbia, Missouri, United States

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States

CCOP - North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Mount Sinai Medical Center, NY; 🇺🇸 New York, New York, United States

New York Presbyterian Hospital - Cornell Campus; 🇺🇸 New York, New York, United States

Veterans Affairs Medical Center - Syracuse; 🇺🇸 Syracuse, New York, United States

Lineberger Comprehensive Cancer Center, UNC; 🇺🇸 Chapel Hill, North Carolina, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Winston-Salem, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital - Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Tennessee, Memphis Cancer Center; 🇺🇸 Memphis, Tennessee, United States

Veterans Affairs Medical Center - Richmond; 🇺🇸 Richmond, Virginia, United States

MBCCOP - Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States

Veterans Affairs Medical Center - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - Minneapolis; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

Veterans Affairs Medical Center - Durham; 🇺🇸 Durham, North Carolina, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

Veterans Affairs Medical Center - Togus; 🇺🇸 Togus, Maine, United States

Veterans Affairs Medical Center - Memphis; 🇺🇸 Memphis, Tennessee, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

CCOP - Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Vermont Cancer Center; 🇺🇸 Burlington, Vermont, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Green Mountain Oncology Group; 🇺🇸 Bennington, Vermont, United States

Veterans Affairs Medical Center - White River Junction; 🇺🇸 White River Junction, Vermont, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States